Pharmacist-led intervention to improve medication use in older inpatients using the Drug Burden Index: a study protocol for a before/after intervention with a retrospective control group and multiple case analysis

Marci Elizabeth Dearing, Susan Bowles, Jennifer Isenor, Olga Kits, Lisa Kouladjian O'Donnell, Heather Neville, Sarah Hilmer, Kent Toombs, Caroline Sirois, Mohammad Hajizadeh, Aprill Negus, Kenneth Rockwood, Emily Reeve, Marci Elizabeth Dearing, Susan Bowles, Jennifer Isenor, Olga Kits, Lisa Kouladjian O'Donnell, Heather Neville, Sarah Hilmer, Kent Toombs, Caroline Sirois, Mohammad Hajizadeh, Aprill Negus, Kenneth Rockwood, Emily Reeve

Abstract

Introduction: Polypharmacy and potentially inappropriate medication use is common in older adults and is associated with adverse outcomes such as falls and hospitalisations.

Methods and analysis: This study is a pharmacist-led medication optimisation initiative using an electronic tool (the Drug Burden Index (DBI) Calculator) in four hospital sites in the Canadian province of Nova Scotia. The study aims to enrol 160 participants between the preintervention and intervention groups. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2013 checklist) was used to develop the protocol for this prospective interventional implementation study. A preintervention retrospective control cohort and a multiple case study analysis will also be used to assess the effect of intervention implementation. Statistical analysis will involve change in DBI scores and assessment of clinical outcomes, such as rehospitalisation and mortality using appropriate statistical tests including t-test, χ2, analysis of variance and unadjusted and adjusted regression methods.

Ethics and dissemination: Ethics approval has been granted by the Nova Scotia Health Authority Research Ethics Board. The findings of this study will be published in peer-reviewed journals and presented at local, national and international conferences.

Trial registration number: NCT03698487.

Keywords: adverse events; clinical pharmacology; geriatric medicine.

Conflict of interest statement

Competing interests: The Drug Burden Index (DBI) Calculator Copyright 2019 The University of Sydney. All rights reserved. SH and LKO are the developers of the DBI Calculator.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Intervention flow chart.
Figure 2
Figure 2
Logic model. DBI, Drug Burden Index.

References

    1. Tannenbaum C. Effect of age, education and health status on community dwelling older men's health concerns. Aging Male 2012;15:103–8. 10.3109/13685538.2011.626819
    1. Tannenbaum C, Mayo N, Ducharme F. Older women's health priorities and perceptions of care delivery: results of the Wow health survey. CMAJ 2005;173:153–9. 10.1503/cmaj.050059
    1. Olsson IN, Runnamo R, Engfeldt P. Medication quality and quality of life in the elderly, a cohort study. Health Qual Life Outcomes 2011;9:95 10.1186/1477-7525-9-95
    1. Muhlack DC, Hoppe LK, Weberpals J, et al. . The association of potentially inappropriate medication at older age with cardiovascular events and overall mortality: a systematic review and meta-analysis of cohort studies. J Am Med Dir Assoc 2017;18:211–20. 10.1016/j.jamda.2016.11.025
    1. Hajjar ER, Cafiero AC, Hanlon JT. Polypharmacy in elderly patients. Am J Geriatr Pharmacother 2007;5:345–51. 10.1016/j.amjopharm.2007.12.002
    1. Scott IA, Hilmer SN, Reeve E, et al. . Reducing inappropriate polypharmacy: the process of deprescribing. JAMA Intern Med 2015;175:827–34. 10.1001/jamainternmed.2015.0324
    1. Nishtala PS, Salahudeen MS, Hilmer SN. Anticholinergics: theoretical and clinical overview. Expert Opin Drug Saf 2016;15:753–68. 10.1517/14740338.2016.1165664
    1. Kouladjian L, Gnjidic D, Chen TF, et al. . Drug burden index in older adults: theoretical and practical issues. Clin Interv Aging 2014;9:1503–15. 10.2147/CIA.S66660
    1. Reeve E, Wiese MD, Mangoni AA. Alterations in drug disposition in older adults. Expert Opin Drug Metab Toxicol 2015;11:491–508. 10.1517/17425255.2015.1004310
    1. Ali-Melkkilä T, Kanto J, Iisalo E. Pharmacokinetics and related pharmacodynamics of anticholinergic drugs. Acta Anaesthesiol Scand 1993;37:633–42. 10.1111/j.1399-6576.1993.tb03780.x
    1. Windle A, Elliot E, Duszynski K, et al. . Benzodiazepine prescribing in elderly Australian general practice patients. Aust N Z J Public Health 2007;31:379–81. 10.1111/j.1753-6405.2007.00091.x
    1. Rockwood K, Song X, MacKnight C, et al. . A global clinical measure of fitness and frailty in elderly people. CMAJ 2005;173:489–95. 10.1503/cmaj.050051
    1. Reeve E, Trenaman SC, Rockwood K, et al. . Pharmacokinetic and pharmacodynamic alterations in older people with dementia. Expert Opin Drug Metab Toxicol 2017;13:651–68. 10.1080/17425255.2017.1325873
    1. Gnjidic D, Hilmer SN, Blyth FM, et al. . High-Risk prescribing and incidence of frailty among older community-dwelling men. Clin Pharmacol Ther 2012;91:521–8. 10.1038/clpt.2011.258
    1. Hilmer SN, Mager DE, Simonsick EM, et al. . A drug burden index to define the functional burden of medications in older people. Arch Intern Med 2007;167:781–7. 10.1001/archinte.167.8.781
    1. Hilmer SN. Calculating and using the drug burden index score in research and practice. Expert Rev Clin Pharmacol 2018;11:1053–5. 10.1080/17512433.2018.1528145
    1. Jamieson HA, Nishtala PS, Scrase R, et al. . Drug burden index and its association with hip fracture among older adults: a national population-based study. J Gerontol A Biol Sci Med Sci 2019;74:1127–33. 10.1093/gerona/gly176
    1. Anderson K, Stowasser D, Freeman C, et al. . Prescriber barriers and enablers to minimising potentially inappropriate medications in adults: a systematic review and thematic synthesis. BMJ Open 2014;4:e006544 10.1136/bmjopen-2014-006544
    1. Nishtala PS, Hilmer SN, McLachlan AJ, et al. . Impact of residential medication management reviews on drug burden index in aged-care homes: a retrospective analysis. Drugs Aging 2009;26:677–86. 10.2165/11316440-000000000-00000
    1. Reeve E, Gnjidic D, Long J, et al. . A systematic review of the emerging definition of 'deprescribing' with network analysis: implications for future research and clinical practice. Br J Clin Pharmacol 2015;80:1254–68. 10.1111/bcp.12732
    1. Masnoon N, Shakib S, Kalisch-Ellett L, et al. . Tools for assessment of the appropriateness of prescribing and association with patient-related outcomes: a systematic review. Drugs Aging 2018;35:43–60. 10.1007/s40266-018-0516-8
    1. Kouladjian L, Gnjidic D, Chen TF, et al. . Development, validation and evaluation of an electronic pharmacological tool: the drug burden index Calculator©. Res Social Adm Pharm 2016;12:865–75. 10.1016/j.sapharm.2015.11.002
    1. Kouladjian O'Donnell L, Gnjidic D, Chen TF, et al. . Integration of an electronic drug burden index risk assessment tool into home medicines reviews: deprescribing anticholinergic and sedative medications. Ther Adv Drug Saf 2019;10:204209861983247–71. 10.1177/2042098619832471
    1. Wouters H, van der Meer H, Taxis K. Quantification of anticholinergic and sedative drug load with the drug burden index: a review of outcomes and methodological quality of studies. Eur J Clin Pharmacol 2017;73:257–66. 10.1007/s00228-016-2162-6
    1. Health Canada, government of Canada Drug product database online query (2019), 2019. Available: [Accessed 01 Aug 2019].
    1. CPS [internet] Ottawa (on): Canadian pharmacists association; c2016, 2019. Available: [Accessed 01 Aug 2019].
    1. Australian new zealand clinical trials registry [internet] Sydney (NSW): NHMRC clinical trials centre, University of Sydney (Australia). identifier. ACTRN12617000765325 minimising the functional burden of medications in older inpatients: implementation of the drug burden index, 2017. Available: [Accessed 01 Aug 2019].
    1. White IR, Daniel R, Royston P. Avoiding bias due to perfect prediction in multiple imputation of incomplete categorical variables. Comput Stat Data Anal 2010;54:2267–75. 10.1016/j.csda.2010.04.005
    1. White IR, Royston P, Wood AM. Multiple imputation using chained equations: issues and guidance for practice. Stat Med 2011;30:377–99. 10.1002/sim.4067
    1. Baxter P, Jack S. Qualitative case study methodology: study design and implementation for novice researchers. Qual. Rep. Nova Southeastern University; School of Social and Systematic Studies, 1990.
    1. Yin R. Case study research: design and methods. Appl. Soc. Res. Methods 2003.
    1. Creswell J. Research design: qualitative, quantitative, and mixed methods approaches. 2nd edn Thousand Oaks: Sage, 2003.
    1. Reeve E, Moriarty F, Nahas R, et al. . A narrative review of the safety concerns of deprescribing in older adults and strategies to mitigate potential harms. Expert Opin Drug Saf 2018;17:39–49. 10.1080/14740338.2018.1397625
    1. Reeve E, Wolff JL, Skehan M, et al. . Assessment of attitudes toward deprescribing in older Medicare beneficiaries in the United States. JAMA Intern Med 2018;178:1673–80. 10.1001/jamainternmed.2018.4720
    1. Sloane PD, Zimmerman S. Deprescribing in geriatric medicine: challenges and opportunities. J Am Med Dir Assoc 2018;19:919–22. 10.1016/j.jamda.2018.09.018
    1. van der Meer HG, Wouters H, Teichert M, et al. . Feasibility, acceptability and potential effectiveness of an information technology-based, pharmacist-led intervention to prevent an increase in anticholinergic and sedative load among older community-dwelling individuals. Ther Adv Drug Saf 2019;10:204209861880588–81. 10.1177/2042098618805881
    1. Sundararajan V, Henderson T, Perry C, et al. . New ICD-10 version of the Charlson comorbidity index predicted in-hospital mortality. J Clin Epidemiol 2004;57:1288–94. 10.1016/j.jclinepi.2004.03.012
    1. Naranjo CA, Busto U, Sellers EM, et al. . A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239–45. 10.1038/clpt.1981.154
    1. Reeve E, Low L-F, Shakib S, et al. . Development and validation of the revised patients' attitudes towards deprescribing (rPATD) questionnaire: versions for older adults and caregivers. Drugs Aging 2016;33:913–28. 10.1007/s40266-016-0410-1
    1. Graves T, Hanlon JT, Schmader KE, et al. . Adverse events after discontinuing medications in elderly outpatients. Arch Intern Med 1997;157:2205–10. 10.1001/archinte.1997.00440400055007
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x
    1. Julayanont P, Tangwongchai S, Hemrungrojn S, et al. . The Montreal cognitive assessment-basic: a screening tool for mild cognitive impairment in illiterate and low-educated elderly adults. J Am Geriatr Soc 2015;63:2550–4. 10.1111/jgs.13820

Source: PubMed

3
구독하다